Greater counterfeit legislation sought

The EAASM is calling for enhanced legislation to improve the protection of Europe's patients against the dangers of counterfeit medicines

The European Alliance for Access to Safe Medicines (EAASM) is calling for enhanced legislation to improve the protection of Europe's patients against the dangers of counterfeit medicines in a report submitted to the European Parliament.

Packaging Patient Protection, published by the EAASM in partnership with stakeholders in patient associations, non-governmental organisations and the pharmaceutical industry, sets out seven key recommendations for new laws to combat fake, counterfeit and substandard medicines.

These include: • a legal obligation for any party in the supply chain unpacking a medicine box to reapply a minimum level of effective traceable and tamper-proof security technology, suggested to take the form of packaging with unique 2D data matrices

• options to ensure that cost should not, as far as possible, be prohibitive in the implementation of universally-supported minimum security provision; however, original manufacturers may choose to supplement this with additional overt or covert security features on particular products. Cost estimates for dual security measures for a typical medium-size pharmaceutical company with an approximate annual turnover of €2.3bn are estimated at €23-€34m, which could be spread over 60 months

• a means by which patients in Europe may recognise medicines that have been tampered with since issue from the original manufacturer.

EAASM chair and CEO of the UK's Centre for Mental Health, Jim Thomson, said: "The EAASM recognises the unique opportunity afforded by the European Commission's proposal for a European Pharmaceutical Package to introduce new legislation that maximises the protection of patients. Patient safety deserves nothing less than stringent new legal provision that excludes any opportunities for counterfeit operations to add risk for Europe's patients. Packaging Patient Protection outlines a means of creating a much-needed safe harbour inclusively and cost-effectively for the distribution and supply of safe medicines."

In May 2009, research by ComRes, commissioned by the EAASM, revealed that 9 out of 10 MEPs and parliamentary candidates surveyed supported action to stop the trade in counterfeit medicines.

More than 80 per cent supported the obligation for safety features to be replaced with others offering an equivalent level of protection and assurance, while more than three-quarters agreed that it should be made possible to identify a medicine pack that has been tampered with and repackaged.